Full Prescribing Info
Flunarizine diHCl.
Fluner also contains sunset yellow FCF as colourant.
Pharmacology: Classification: Drugs affecting autonomic functions. Antihistamines.
Mechanism of Action: Flunarizine is a selective calcium antagonist. It prevents cellular calcium overload by reducing excessive transmembrane calcium influxes. Flunarizine is well absorbed from the gut, reaching peak plasma levels within 2-4 hrs and reaching steady state at 5-6 weeks. After extensive hepatic metabolism, flunarizine and its metabolites are excreted through the faeces via the bile. The mean terminal elimination t1/2 is about 18 days. Plasma protein-binding is 99%.
Prophylaxis of classic (with aura) or common (without aura) migraine.
Symptomatic treatment of vestibular vertigo (due to a diagnosed functional disorder of the vestibular system).
Dosage/Direction for Use
Migraine Prophylaxis: Starting Dose: 1 tab Fluner 10 mg at night in patients <65 years and 1 tab Fluner 5 mg daily in patients >65 years.
If after 2 months of this initial treatment, no significant improvement is observed, the patient should be considered a non-responder and administration should be discontinued.
Maintenance Treatment: If a patient is responding satisfactorily and if a maintenance treatment is needed, the dose should be decreased to 5 days of treatment at the same daily dose with 2 successive medicine-free days every week.
Even if the prophylactic maintenance treatment is successful and well tolerated, it should be interrupted after 6 months and it should be reinitiated only if the patient relapses.
Vertigo: The same dosage should be used as for migraine, but the starting treatment should not be given longer than needed for symptom control, which generally takes <2 months.
If after 1 month of treatment for chronic vertigo or after 2 months treatment for paroxysmal vertigo, no significant improvement is observed, the patient should be considered a non-responder and administration should be discontinued.
Hypersensitivity to flunarizine; history of depressive illness or preexisting symptoms of Parkinson's disease or other extrapyramidal disorders.
Special Precautions
Fluner is not suited for aborting a migraine attack. The possible occurrence of an attack is therefore no reason to increase the dose of Fluner.
Fluner treatment may give rise to extrapyramidal and depressive symptoms and reveal parkinsonism especially in predisposed patients eg, the elderly. Fluner should therefore be used with caution in such patients.
Fluner should be used with care in patients with depression or those being prescribed other agents eg, phenothiazines, concurrently, which may cause extrapyramidal side effects.
Fatigue may increase progressively during Fluner therapy; in this event, therapy should be discontinued.
The recommended dose should not be exceeded. Patients should be seen at regular intervals, especially during maintenance treatment so that extrapyramidal or depressive symptoms may be detected early and if so, treatment discontinued. If during maintenance treatment the therapeutic effects subside, treatment should also be discontinued (see Dosage & Administration).
Effects on the Ability to Drive or Operate Machinery: Fluner may lead to drowsiness which is aggravated by the simultaneous intake of alcohol or other CNS depressants. Patients should be cautioned against driving motor vehicles or performing other potentially hazardous tasks where a loss of mental alertness may lead to accidents.
Use in pregnancy & lactation: Safety in pregnancy and lactation has not been established.
Use In Pregnancy & Lactation
Safety in pregnancy and lactation has not been established.
Adverse Reactions
Drowsiness and/or fatigue, as well as weight gain and/or increased appetite may occur.
The following adverse experiences have been reported during chronic treatment with Fluner: Depression, of which female patients with a history of depressive illness may be particularly at risk; extrapyramidal symptoms (eg, bradykinesia, rigidity, akathisia, orofacial dyskinesia, tremor), of which elderly patients seem particularly at risk.
Infrequently reported adverse reactions are: Heartburn, nausea, gastralgia, insomnia, anxiety, galactorrhoea, dry mouth, muscle ache, skin rash.
Drug Interactions
Galactorrhoea has been reported in few women on oral contraceptives within the first 2 months of Fluner treatment.
Hepatic enzyme inducers eg, carbamazepine and phenytoin may interact with flunarizine by increasing its metabolism. An increase in dosage of flunarizine may be required.
Store in a cool, dark and dry place.
MIMS Class
Antimigraine Preparations
ATC Classification
N07CA03 - flunarizine ; Belongs to the class of antivertigo preparations.
Tab 5 mg x 2 x 5 x 10's. 10 mg x 2 x 5 x 10's.
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